The European Commission has granted marketing authorisation for mRESVIA®, a respiratory syncytial virus (RSV) vaccine developed by Moderna, Inc. (NASDAQ). The vaccine is designed to protect adults aged 60 and older from lower respiratory tract diseases caused by RSV infection.
This approval, which follows a positive opinion from the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP), marks a significant milestone in public health. It is the first time a messenger RNA (mRNA) vaccine has been authorised for use in Europe for a disease other than COVID-19. The decision is effective across all 27 EU member states, as well as Iceland, Liechtenstein, and Norway.
Stéphane Bancel, Moderna’s Chief Executive Officer, described the approval as a crucial achievement for public health. “mRESVIA safeguards older adults against severe RSV outcomes and is uniquely offered in a pre-filled syringe to enhance ease of administration, which can reduce vaccine preparation time and administrative errors,” Bancel stated.
RSV is a highly contagious seasonal virus that poses a significant threat, particularly to infants and older adults. It is one of the leading causes of lower respiratory tract infections and pneumonia in Europe. Annually, RSV is estimated to cause approximately 160,000 hospitalisations in adults within the EU, with 92% of these occurring in those aged 65 and older.
The authorisation of mRESVIA is based on data from the Phase 3 ConquerRSV trial, a global study involving approximately 37,000 adults aged 60 and above across 22 countries. The trial results, published in The New England Journal of Medicine, showed a vaccine efficacy of 83.7% against RSV-related lower respiratory tract disease (LRTD) in the initial analysis, with a median follow-up of 3.7 months. Subsequent analyses demonstrated that the vaccine maintained a durable efficacy of 63.3% after 8.6 months, confirming its long-term protective benefits.
The vaccine employs Moderna’s established lipid nanoparticles (LNPs) technology, used in their COVID-19 vaccines, to deliver an mRNA sequence encoding a stabilised prefusion F glycoprotein. This protein, crucial for the virus’s ability to infect host cells, is a key target for neutralising antibodies.
In May 2024, mRESVIA received approval from the U.S. Food and Drug Administration (FDA) under a breakthrough therapy designation. Moderna is currently pursuing additional marketing authorisations for the vaccine in several markets worldwide.